The
World Health Organization has updated Annex 10 of its GMPs “WHO general guidance
on variations to multisource pharmaceutical products.”
According
to the document:
“A
marketing authorization (MA) holder or applicant is responsible for the quality,
safety and efficacy (QSE) of a finished pharmaceutical product (FPP) that is
placed on the market, throughout its life cycle. After the FPP has been authorized
for marketing, the manufacturer will often wish to make changes (variations)
for a number of reasons, for example, to respond to technical
and scientific progress, to improve the quality of the FPP, to apply updates to
the retest period for the active pharmaceutical ingredient (API) or shelf life of
the FPP, to meet market requirements such as for scale-up or additional manufacturing
sites, or to update product information (e.g. the information on adverse
reactions). Such changes, regardless of their nature, are referred to as variations
and may require the approval of the national medicines regulatory authority
(NMRA) prior to implementation.”Posted by Dr. Tim Sandle
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